WO2012000462A1 - Préparation immunobiologique pour le traitement de maladies cutanées auto-immunes, particulièrement du psoriasis - Google Patents

Préparation immunobiologique pour le traitement de maladies cutanées auto-immunes, particulièrement du psoriasis Download PDF

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Publication number
WO2012000462A1
WO2012000462A1 PCT/CZ2011/000066 CZ2011000066W WO2012000462A1 WO 2012000462 A1 WO2012000462 A1 WO 2012000462A1 CZ 2011000066 W CZ2011000066 W CZ 2011000066W WO 2012000462 A1 WO2012000462 A1 WO 2012000462A1
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WO
WIPO (PCT)
Prior art keywords
psoriasis
treatment
skin
preparation
bacillus megaterium
Prior art date
Application number
PCT/CZ2011/000066
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English (en)
Inventor
Tomas Urbanek
Original Assignee
Tomas Urbanek
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tomas Urbanek filed Critical Tomas Urbanek
Publication of WO2012000462A1 publication Critical patent/WO2012000462A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/742—Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics

Definitions

  • the invention relates to a new immunobiological preparation suitable for the treatment of autoimmune skin diseases, particularly psoriasis, and to the use of this preparation in therapy.
  • the treatment of psoriasis can be divided into the following basic categories: use of topical medications (medications applied to the skin), phototherapy, or a combination of phototherapy and other medications, systemic therapy (medicines administered by injection or in tablets), biological treatment.
  • topical medications medications applied to the skin
  • phototherapy or a combination of phototherapy and other medications
  • systemic therapy medicines administered by injection or in tablets
  • biological treatment A number of factors such as the type of psoriasis, the location of the affected area on the body, the severity of the symptoms, the patient's age and their anamnesis, the patient's response to a previous treatment, decide, which treatment is appropriate for the respective patient.
  • the topical therapy is usually used as the first option in the treatment of psoriasis. After the application the medicines act on a removal of lesions relatively quickly and are usually well tolerated. However, for the topical preparations to be active it is essential to use them repeatedly, because they are insufficient for the preservation of the temporary disappearance of psoriatic symptoms. They can also stain and their application can be lengthy, if psoriasis affects a larger part of the body.
  • Dithranol is used as a medicine, or in combination with UVB rays therapy. However, this medicine often causes skin irritation and burning. Additionally, everything that comes into contact with the medicine is stained.
  • Topically applied corticosteroids are medicines similar to naturally occurring hormones of the human body. They are available in many different efficacies and pharmaceutical formulation types such as creams, lotions, moisturisers, sprays, ointments and medicated plasters. Corticosteroids act in patients with psoriasis in such a way that they slow down the growth of skin cells and reduce inflammation of the lesions. Although corticosteroids can quickly remove the lesions, it is typical for them that the remission caused by them does not last for a long time, so that the lesions associated with psoriasis reappear after a short period of time.
  • Topically applied coal tar can be used alone or in combination with UVB.
  • the coal tar usage is very restricted by its ability to stain everything around and especially by the fact that coal is a proven carcinogen.
  • Calcipotriol Vitamin D analogue
  • Calcitriol and Tacalcitol substances were introduced later. Calcipotriol showed equal or better efficacy than other preparations and it is more acceptable from the cosmetic point of view and generally well tolerated.
  • Salicylic acid is a substance which helps to remove the scales from the lesions. This allows the application of topical preparations and their better penetration into the skin. It can be used in the form of a paste, a cream, an ointment or a solution.
  • OTC over-the-counter
  • phototherapy is suitable for the patients with psoriasis unresponsive to topical therapy or where psoriasis is too widespread. Its principle is skin exposure to ultraviolet radiation, which has a therapeutic effect on psoriasis.
  • the ultraviolet radiation can be either natural, as part of solar radiation, or artificial, from special lamps emitting radiation in a narrow band around the optimal wavelength of 31 1 nm.
  • the PUVA method also called Photo-Chemotherapy, was developed in 1970s and is based on a combination of a preparation increasing the sensitivity to light (Psoralen) followed by irradiation with ultraviolet rays UVA (like UVB, UVA occurs in natural light). Psoralen induces a higher sensitivity of the skin and its stronger reaction to this type of ultraviolet radiation. A long-term PUVA therapy can lead to premature skin aging and also significantly increases the risk of skin cancer (basal cell carcinoma and carcinoma of superficial skin cells).
  • Methotrexate a substance that has a long-term use is associated with liver damage. In many countries it is therefore required that patients, who use Methotrexate for a long time, undergo a routine liver biopsy examination. It acts such a way that it binds to an enzyme involved in cell growth, and thereby slows down the growth of pathologically altered skin cells caused by psoriasis.
  • the biological treatment of psoriasis represents a significant advance in the treatment of this disease. It is an effective treatment, long-term safe, comfortable and well- tolerated by patients. It is destined for a defined group of people suffering from psoriasis, who cannot be effectively treated with the current systemic therapy. These patients are therefore given a full personal life and position in society comparable to a healthy population.
  • the biological therapy offers a high efficacy and an improved safety because of using targeted medicines based on natural proteins, which interfere with certain steps in the pathogenesis of psoriasis.
  • Biological preparations are targeted at the immune system, where they block the activity of certain immune system cells, which are of importance in the pathogenesis of psoriasis. While other treatment options for psoriasis, such as PUVA, Methotrexate and Cyclosporin, also affect the immune system, the effect of biological preparations is more specific and these preparations can be safer.
  • the first group of medicines developed specifically for psoriasis, include Efalizumab (Raptiva), which specifically affects T- cells and thus has a specific effect on the skin.
  • Medicines from the other group e. g. Etanercept (Enbrel), Infliximab (Remicade), Adalimumab (Humira)
  • Etanercept Enbrel
  • Infliximab Remicade
  • Adalimumab Humira
  • the object of the present invention is an immunobiological preparation, which contains at least one active ingredient selected from the group comprising of inactivated cells of Bacillus megaterium culture and Bacillus megaterium culture filtrate.
  • inactivated cells of Bacillus megaterium culture refers to cells, which are prepared by any of the known methods of inactivation, e.g. fractional sterilization.
  • the Bacillus megaterium is preferably selected from the group consisting of Bacillus megaterium strains: 1/32, 2/37, 3/39, 4/58 and 5/74 according to the CNCTC (the Czech National Collection of Type Cultures), Catalogue of Strains - 5th Edition, p. 5.
  • the object of the invention is also a preparation according to the present invention for use in the treatment of an autoimmune skin disease, preferably in the treatment of psoriasis.
  • the preparation according to the present invention is preferably administered in the form of a subcutaneous injection.
  • the preparation can be administered again at an interval of 2 to 3 weeks, if the desired clinical effect fails to appear within one week after the first dose.
  • Figure 1 shows a table for the calculation of the PASI score.
  • Figure 2 represents a chart showing changes in the average PASI score of monitored subjects according to Example 3 at time. Examples of Carrying Out the Invention
  • Bacillus megaterium de Bary (hereinafter referred to as Bacillus megaterium), the strains - 1/32, 2/37, 3/39, 4/58, 5/74.
  • the vial is incised by a file.
  • the surface of the vial is disinfected.
  • the dry matter is dissolved by adding a few drops of meat peptone broth (the preparation is described below)
  • This solution is aseptically poured into 1 litre of meat peptone broth, which is a multi-purpose medium for the cultivation of microorganisms. Then the incubation follows.
  • Procedure of preparation The above ingredients are weighed into 1 ,000.0 ml of distilled water (into a sterile Erlenmeyer flask) and heated up to a complete dissolution. Then the flask and its contents are sterilized in an autoclave at 121 °C for 20 minutes.
  • the flask and its contents is retained for 1 week at 37 °C - aerobically.
  • the growth of the culture is manifested through the turbidity of the contents of the flask.
  • the flask with its contents is heated to 100 °C for 30 minutes and then left for 24 hours at 37 °C. Under these conditions the possibly present spores germinate. The grown vegetative forms are destroyed by a triple repetition of this procedure.
  • 1 ml of the preparation is administered subcutaneously by an injection to the patient on the dorsolateral side of the arm.
  • the antipsoriatic therapeutic effect usually begins to show up in a week after the application of the preparation. If the therapeutic effect does not appear, the application is repeated within 2 to 3 weeks after the previous dose. This procedure can be repeated up to 3 times with the application into the second arm than in the one where the previous dose was administered.
  • Psoriasis severity is assessed by the PASI score (Psoriasis Area and Severity Index - this is a scoring system, under which redness, induration and desquamation of the skin are assessed), where the PASI score 0 indicates the absence of psoriasis disease and the PASI score of 72 means the maximum skin involvement.
  • PASI score Psoriasis Area and Severity Index - this is a scoring system, under which redness, induration and desquamation of the skin are assessed
  • the evaluation was based on an assessment of skin psoriasis infliction in categories: redness, induration, and desquamation of individual studied subjects.
  • the PASI scores were calculated according to the table shown in Figure 1 on Days -14, 0, 10, 14, 21, 28, 56, 90 and 180.
  • the overall effect of the treatment for the study subject was evaluated on Day 180 as follows: The deterioration was defined as the PASI score higher than the PASI score on Day 0.
  • a highly significant improvement was defined as a PASI score decrease of 76 to 100 percent in comparison with the PASI score on Day 0.
  • Number of evaluated subjects 25, including 7 women and 18 men

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Mycology (AREA)
  • Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une préparation immunobiologique qui contient au moins un principe actif choisi dans le groupe comprenant des cellules inactivées de culture de Bacillus megaterium et un filtrat de culture de Bacillus megaterium. Ladite préparation immunobiologique peut être utilisée dans le traitement d'une maladie cutanée auto-immune, de préférence dans le traitement du psoriasis.
PCT/CZ2011/000066 2010-06-28 2011-06-27 Préparation immunobiologique pour le traitement de maladies cutanées auto-immunes, particulièrement du psoriasis WO2012000462A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CZ20100511A CZ302713B6 (cs) 2010-06-28 2010-06-28 Imunobiologický prípravek pro lécbu autoimunitních onemocnení kuže, zejména psoriázy
CZPV2010-511 2010-06-28

Publications (1)

Publication Number Publication Date
WO2012000462A1 true WO2012000462A1 (fr) 2012-01-05

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PCT/CZ2011/000066 WO2012000462A1 (fr) 2010-06-28 2011-06-27 Préparation immunobiologique pour le traitement de maladies cutanées auto-immunes, particulièrement du psoriasis

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CZ (1) CZ302713B6 (fr)
WO (1) WO2012000462A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030194412A1 (en) * 2001-06-05 2003-10-16 The Regents Of The University Of Michigan Nanoemulsion vaccines
WO2005110445A2 (fr) * 2004-05-11 2005-11-24 Ganeden Biotech, Inc. Procedes et compositions de gestion alimentaire de troubles auto-immuns

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030078404A1 (en) * 2001-08-15 2003-04-24 Millennium Pharmaceuticals, Inc. 33297, a human cytochrome P450 family member and uses therefor

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030194412A1 (en) * 2001-06-05 2003-10-16 The Regents Of The University Of Michigan Nanoemulsion vaccines
WO2005110445A2 (fr) * 2004-05-11 2005-11-24 Ganeden Biotech, Inc. Procedes et compositions de gestion alimentaire de troubles auto-immuns

Also Published As

Publication number Publication date
CZ2010511A3 (cs) 2011-09-14
CZ302713B6 (cs) 2011-09-14

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